NCT05015491已完成不适用
A Single Arm Study to Assess the Effects of Online App Weight Loss Programs on Liver Health in Obese Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Noom Inc.
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Change in BMI
研究概览
简要总结
The primary objective of this trial is to assess the effects of online app weight loss programs on liver health in obese adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, >18 years of age, inclusive, at Day -
- •BMI of 30.00 to 49.99 kg/m2, inclusive, at Day -
- •Has no plan to change smoking habits during the study period.
- •Has ability to access study related online programs and apps.
- •Willing to follow study instructions, as well as complete online questionnaires.
- •Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigators, Sponsor and Collaborator.
排除标准
- •Self-reported presence of uncontrolled cardiac, renal, endocrine, pulmonary, biliary, pancreatic, gastrointestinal, or neurological disorders or cancer (except for non-melanoma skin cancer) that may affect the subject's ability to adhere to the study protocol and/or affect study outcomes as assessed by the PI.
- •Self-reported type 1 diabetes.
- •History of gastrointestinal surgery for weight reducing purposes.
- •Participation in a weight loss trial or a program/service intended to alter body weight (e.g., Noom, Weight Watchers); medications, dietary supplements or products that affect weight loss, nutrient absorption, appetite and satiety; or weight loss or gain ≥10 lb (4.5 kg) within 6 mo of Day -
- •Extreme dietary habits (e.g., Atkins diet, very high protein, intermittent fasting) or eating disorder.
- •Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded.
- •Female with prior medical diagnosis of premenstrual syndrome or premenstrual dysphoric disorder.
- •Unstable use of hormonal contraceptives, anti-hypertensive medication, medications for mental or emotional disorders, or thyroid hormones within 90 d of Day -
- •Exposure to any non-registered drug product within 30 d of Day -
- •Recent history of (within 12 mo of Day -7) or strong potential for alcohol or substance abuse. Alcohol abuse defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or
- •1½ oz distilled spirits).
- •ALT or AST > 5 x ULN at baseline.
结局指标
主要结局
Change in BMI
时间窗: baseline to day 112
BMI
次要结局
- Fibroscan - from baseline to day 112(Baseline to day 112)
- Fibroscan(Baseline to day 112)
- Change Weight Efficacy Life-Style (WEL) subscale scores (negative emotion, availability, social pressure, physical discomfort, and positive activities) and a global score(Baseline to day 168)
- Change in RAND-36 domain scores (emotional well-being, energy/fatigue, general health, pain, physical functioning, role limitations due to emotional problems, role limitations due to physical health, and social functioning).(Baseline to day 168)
研究者
研究点 (2)
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